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Objectives: To assess the relation between the number of clinical trials conducted and respective new drug approvals in India and South Africa.
Design: Construction and analysis of a comprehensive database of completed randomised controlled clinical trials based on clinicaltrials.gov from 1 January 2005 to 31 December 2010 and drug approval data from 2006 until 2013 for India and South Africa.
Setting: USA, the EU, India and South Africa.
Main outcome measures: Percentage of completed randomised clinical trials for an Investigational Medicinal Product (IMP) leading to new drug approval in India and South Africa.
Results: A total of 622 eligible randomised controlled trials were identified as per search criteria for India and South Africa. Clustering them for the same sponsor and the same Investigational New Drug (IND) resulted in 453 eligible trials, that is, 224 for India and 229 for South Africa. The distribution of the market application approvals between the EU/USA as well as India and South Africa revealed that out of clinical trials with the participation of test centres in India and/or South Africa, 39.6% (India) clinical trials and 60.1% (South Africa) clinical trials led to market authorisation in the EU/USA without a New Drug Application (NDA) approval in India or South Africa.
Conclusions: Despite an increase in clinical trial activities, there is a clear gap between the number of trials conducted and market availability of these new drugs in India and South Africa. Drug regulatory authorities, investigators, institutional review boards and patient groups should direct their efforts to ensuring availability of new drugs in the market that have been tested and researched on their population.
BACKGROUND: Even though physician rating websites (PRWs) have been gaining in importance in both practice and research, little evidence is available on the association of patients' online ratings with the quality of care of physicians. It thus remains unclear whether patients should rely on these ratings when selecting a physician. The objective of this study was to measure the association between online ratings and structural and quality of care measures for 65 physician practices from the German Integrated Health Care Network "Quality and Efficiency" (QuE). METHODS: Online reviews from two German PRWs were included which covered a three-year period (2011 to 2013) and included 1179 and 991 ratings, respectively. Information for 65 QuE practices was obtained for the year 2012 and included 21 measures related to structural information (N = 6), process quality (N = 10), intermediate outcomes (N = 2), patient satisfaction (N = 1), and costs (N = 2). The Spearman rank coefficient of correlation was applied to measure the association between ratings and practice-related information. RESULTS: Patient satisfaction results from offline surveys and the patients per doctor ratio in a practice were shown to be significantly associated with online ratings on both PRWs. For one PRW, additional significant associations could be shown between online ratings and cost-related measures for medication, preventative examinations, and one diabetes type 2-related intermediate outcome measure. There again, results from the second PRW showed significant associations with the age of the physicians and the number of patients per practice, four process-related quality measures for diabetes type 2 and asthma, and one cost-related measure for medication. CONCLUSIONS: Several significant associations were found which varied between the PRWs. Patients interested in the satisfaction of other patients with a physician might select a physician on the basis of online ratings. Even though our results indicate associations with some diabetes and asthma measures, but not with coronary heart disease measures, there is still insufficient evidence to draw strong conclusions. The limited number of practices in our study may have weakened our findings.
The IfBB – Institute for Bioplastics and Biocomposites is a research institute within the Hochschule Hannover, University of Applied Sciences and Arts, which was established in 2011 to respond to the growing need for expert knowledge in the area of bioplastics. With its practice-oriented research and its collaboration with industrial partners, the IfBB is able to shore up the market for bioplastics and, in addition, foster unbiased public awareness and understanding of the topic. As an independent research-led expert institution for bioplastics, the IfBB is willing to share its expertise, research findings and data with any interested party via the Internet, online and offline publications or at fairs and conferences. In carrying on these efforts, substantial information regarding market trends, processes and resource needs for bioplastics is being presented here in a concise format, in addition to the more detailed and comprehensive publication and “Engineering Biopolymers”1.
One of our main concerns is to furnish a more rational basis for discussing bioplastics and use fact-based arguments in the public discourse. Furthermore, “Biopolymers – facts and statistics” aims to provide specific, qualified answers easily and quickly for decision-makers in particular from public administration and the industrial sector. Therefore, this publication is made up like a set of rules and standards and largely foregoes textual detail. It offers extensive market-relevant and technical facts presented in graphs and charts, which means that the information is much easier to grasp. The reader can expect comparative market figures for various materials, regions, applications, process routes, agricultural land use or resource consumption, production capacities, geographic distribution, etc.
Inhalt dieser Seminararbeit ist eine Untersuchung 20 großer Open-Access-Publisher zur Beantwortung der Fragen, welche der Publisher die Artikel in den von ihnen herausgegebenen Journals neben PDF auch strukturiert anbieten und welche zusätzlichen Features gegebenenfalls angeboten werden. Der Untersuchung liegen jeweils mindestens zwei Journals eines Publishers zugrunde. Die Arbeit wurde als Leistungsnachweis für die Lehrveranstaltung „Aktuelle Entwicklungen im Informationsmanagement“ im WS 2014/15 angefertigt.
Die automatisierte Bewertung studentischer Übungsabgaben in Programmieren-Lehrveranstaltungen weist Parallelen zum automatisierten Test in der professionellen Softwareentwicklung auf. Allerdings muss ein Autobewerter (Grader), um lernförderlich zu sein, andere Zielsetzungen erfüllen als üblicherweise im professionellen Softwaretest eingesetzte Analyse- und Testwerkzeuge. Dieser Beitrag identifiziert wesentliche Unterschiede und beschreibt, wie sich diese Unterschiede in dem an der Hochschule Hannover entwickelten und seit mehreren Jahren im Einsatz befindlichen Autobewerter "Graja" niederschlagen.
End users urgently request using mobile devices at their workplace. They know these devices from their private life and appreciate functionality and usability, and want to benefit from these advantages at work as well. Limitations and restrictions would not be accepted by them. On the contrary, companies are obliged to employ substantial organizational and technical measures to ensure data security and compliance when allowing to use mobile devices at the workplace. So far, only individual arrangements have been presented addressing single issues in ensuring data security and compliance. However, companies need to follow a comprehensive set of measures addressing all relevant aspects of data security and compliance in order to play it safe. Thus, in this paper at first technical architectures for using mobile devices in enterprise IT are reviewed. Thereafter a set of compliance rules is presented and, as major contribution, technical measures are explained that enable a company to integrate mobile devices into enterprise IT while still complying with these rules comprehensively. Depending on the company context, one or more of the technical architectures have to be chosen impacting the specific technical measures for compliance as elaborated in this paper. Altogether this paper, for the first time, correlates technical architectures for using mobile devices at the workplace with technical measures to assure data security and compliance according to a comprehensive set of rules.
Die vorliegende Arbeit befasst sich mit der Erschließung historischer Bestände nach RDA. Inhaltlich begrenzt sie sich auf ausgewählte spezifische Merkmale alter Drucke und ihrer Formalerschließung mit RDA. Die Umstellung auf das neue Regelwerk, welches Anwen-dungsrichtlinien für alle Materialien vereinen soll, und einige in den Bibliotheksgremien diskutierte Aspekte wie z. B. „cataloger’s judgement“ haben die zentrale Frage dieser Arbeit veranlasst: Ist RDA für die Erschließung alter Drucke geeignet?
Die Arbeit untersucht spezifische Merkmale alter Drucke. Sie betrachtet die bestehende Erschließungspraxis alter Drucke und geht auf die Grundlagen und wesentliche Inhalte von RDA ein. Zu wissenschaftlichen Methoden der Arbeit gehören der Regelwerkevergleich und das Experteninterview. Die Gegenüberstellung von RDA und den RAK-WB lässt erkennen, dass RDA sich prinzipiell für die Erschließung alter Drucke eignet und Elemente der bibliographischen Beschreibung ähnlich wie die RAK-WB abbildet. Wegen des allgemeinen Charakters sind einige Richtlinien von RDA noch zu konkretisieren. Mehrwert gegenüber den RAK-WB versprechen die normierten Sucheinstiege, die Erfassung von Werken und Beziehungen. Das Interview mit Christoph Boveland, dem Experten auf dem Gebiet Katalogisierung Alter Drucke, bringt neue Erkenntnisse über geplante Empfehlungen zur Erschließung alter Drucke mit RDA, Erweiterung des Standardelemente-Set usw. Basierend auf den Ergebnissen der Gegenüberstellung und der Meinung von Christoph Boveland wird eine Aussage zur Entwicklung der Lehrveranstaltung „Formalerschließung historischer Bestände“ an der Hochschule Hannover getroffen.
This article discusses event monitoring options for heterogeneous event sources as they are given in nowadays heterogeneous distributed information systems. It follows the central assumption, that a fully generic event monitoring solution cannot provide complete support for event monitoring; instead, event source specific semantics such as certain event types or support for certain event monitoring techniques have to be taken into account. Following from this, the core result of the work presented here is the extension of a configurable event monitoring (Web) service for a variety of event sources. A service approach allows us to trade genericity for the exploitation of source specific characteristics. It thus delivers results for the areas of SOA, Web services, CEP and EDA.
„Grappa“ ist eine Middleware, die auf die Anbindung verschiedener Autobewerter an verschiedene E-Learning-Frontends respektive Lernmanagementsysteme (LMS) spezialisiert ist. Ein Prototyp befindet sich seit mehreren Semestern an der Hochschule Hannover mit dem LMS „moodle“ und dem Backend „aSQLg“ im Einsatz und wird regelmäßig evaluiert. Dieser Beitrag stellt den aktuellen Entwicklungsstand von Grappa nach diversen Neu- und Weiterentwicklungen vor. Nach einem Bericht über zuletzt gesammelte Erfahrungen mit der genannten Kombination von Systemen stellen wir wesentliche Neuerungen der moodle-Plugins, welche der Steuerung von Grappa aus moodle heraus dienen, vor. Anschließend stellen wir eine Erweiterung der bisherigen Architektur in Form eines neuentwickelten Grappa-php-Clients zur effizienteren Anbindung von LMS vor. Weiterhin berichten wir über die Anbindung eines weiteren Autobewerters „Graja“ für Programmieraufgaben in Java. Der Bericht zeigt, dass bereits wichtige Schritte für eine einheitliche Darstellung automatisierter Programmbewertung in LMS mit unterschiedlichen Autobewertern für die Studierenden absolviert sind. Die praktischen Erfahrungen zeigen aber auch, dass sowohl bei jeder der Systemkomponenten individuell, wie auch in deren Zusammenspiel via Grappa noch weitere Entwicklungsarbeiten erforderlich sind, um die Akzeptanz und Nutzung bei Studierenden sowie Lehrenden weiter zu steigern.
This paper describes the latest accomplishments on the current research that is based on the master’s thesis “Ein System zur Erstellung taktiler Karten für blinde und sehbehinderte Menschen” (German for “A system creating tactile maps for blind and visually impaired people”) (Hänßgen, 2012). The system consists of two parts. The first part is new software especially designed and developed for creating tactile maps addressing the needs of blind and visually impaired people on tactile information. The second is an embossing device based on a modified CNC (computer numerical control) router. By using OpenStreetMap-data, the developed system is capable of embossing tactile maps into Braille paper and writing film.